Back Pain, Chronic Pain, Neck Pain, Osteoarthritis
Conditions
Keywords
Acupuncture, Group/Community Acupuncture, Individual Acupuncture, Chronic Pain, Underserved, Urban Primary Care, Osteoarthritis, Back Pain, Neck Pain
Brief summary
Chronic pain is a major public health problem that places many burdens on individuals, including impairment of physical and psychological functioning, lost productivity, and side effects of medications used to treat pain. There is also substantial evidence that minority populations differ both in prevalence and outcomes of chronic pain; access to care is a key component in these differences. Strong evidence now supports the use of acupuncture in the treatment of chronic pain conditions, including when provided in the primary care setting to participants from ethnically diverse, medically underserved populations. Acupuncture is slowly being integrated into pain management in many conventional health care settings, but cost and reimbursement for this service remain obstacles to offering acupuncture, especially in primary care and safety net settings. Because group acupuncture can be offered at much lower cost, demonstrating that individual and group delivery are equally effective could reduce barriers to use of this effective pain management approach. The primary aim of this study will be to evaluate whether acupuncture delivered in the group setting for participants with chronic pain is equal to acupuncture delivered in the individual setting. A secondary objective will be to use qualitative analysis to understand and describe the participants' experience of both acupuncture approaches, and to utilize this data to inform intervention delivery and dissemination, to better incorporate the participants' perspective.
Interventions
PROCEDUREGroup/Community Acupuncture
Acupuncture treatment in a group setting.
PROCEDUREIndividual Acupuncture
Acupuncture treatment in an individual setting.
Sponsors
Montefiore Medical Center
Mount Sinai Beth Israel Department of Integrated Medicine
Pacific College of Oriental Medicine
Patient-Centered Outcomes Research Institute
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Referred by a primary care provider from one of our participating primary care health centers * Provider-documented diagnosis of osteoarthritis (any joint), neck pain, OR back pain * Self-reported pain score of ≥4 for at least 3 months prior to program entry * Able to provide consent for treatment and data collection in either English or Spanish
Exclusion criteria
* \< 21 years of age * Chronic pain not documented OR self reported pain of ≥4 for less than 3 months. * Currently taking oral or injectable anticoagulants. * Lack of contact information OR unavailable for duration of entire treatment period (24 weeks) * Inability to consent to treatment and data collection. * Active psychosis * Active substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much the participants' pain interferes with daily life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Investigators measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)) | The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | Baseline, Week 12 (End of Treatment Window) | The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in their pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed. |
| Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | Baseline, Week 12 (End of Treatment) | The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed. |
| Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | Baseline, Week 24 (12 weeks after treatment window) | The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis. |
| Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | Baseline, Week 24 (12 weeks after treatment window) | The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment). The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were included in the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model) | Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model) | Week 12 (end of treatment window), and week 24 (12 weeks after treatment window) | The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model) | Week 12 (End of Treatment Window) | The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \>=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis. |
| Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model) | Week 12 (End of Treatment Window) | The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \>=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were included in the analysis. |
| Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model) | Week 24 (12 Weeks After Treatment Window | The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \>=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis. |
| Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model) | Week 24 (12 Week After Treatment Window) | The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \>=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis. |
| Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.. |
| Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | Baseline, Week 12 (End of treatment window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \>=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who have been randomized into treatment. Only patients who completed a week 12 questionnaire were included in the analysis. |
| Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | Baseline, Week 12 (End of Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \>=2-point increase is considered a 30% improvement. The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis. |
| Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | Baseline, Week 24 (12 Weeks After Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \>=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis. |
| Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | Baseline, Week 24 (12 Weeks After Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as a \>= 2-point increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis. |
| Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and then divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is anyone who intended to receive treatment; in our case, it is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | Baseline, Week 12 (End of Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \>=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis. |
| Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | Baseline, Week 12 (End of Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \>=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis. |
| Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | Baseline, Week 24 (12 Weeks After Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \>=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis. |
| Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | Baseline, Week 24 (12 Weeks After Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \>=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis. |
| Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of intent to treat is all participants who have been randomized into treatment. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Medical Record (EMR) Data (Intent to Treat Model) | 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment) | Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME for participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months prior and post-treatment). A smaller MME indicates that the participant was using less medication. The definition of intent to treat is all participants who were randomized into treatment. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams). |
| Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Record (EMR) Data (Per Protocol Model) | 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment) | Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME of participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months pre- and 3 months post-treatment). A smaller MME indicates that the participant was using less medication. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams). |
| Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model) | 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment) | Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 months post-treatment). The definition of intent to treat is all participants who were randomized into treatment. There were 191 total participants that had any documented opioid prescriptions in EMR. |
| Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model) | 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment) | Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 month post-treatment). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. |
| Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window) | The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data. |
| Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | Baseline, Week 12 (End of Treatment Window) | The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed. |
| Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | Baseline, Week 12 (End of Treatment Window) | The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed. |
| Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | Baseline, Week 24 (12 Weeks After Treatment Window) | The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were analyzed. |
| Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | Baseline, Week 24 (12 Weeks After Treatment Window) | The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were analyzed. |
Countries
United States
Participant flow
Recruitment details
Participants were referred by their primary care providers (PCPs) from their participating health care center. For patients who met the eligibility criteria, PCPs completed a study-specific referral form and obtained permission to contact the patient by phone. Participants were then contacted by the study staff and screened for eligibility.
Pre-assignment details
Participants were screened by phone and completed an oral consent. They were mailed a treatment consent form and told to contact the study team in order to complete the baseline and receive their treatment arm. Several participants were excluded for various reasons including ineligibility and declining participation.
Participants by arm
| Arm | Count |
|---|---|
| Group Acupuncture Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks. | 389 |
| Individual Acupuncture Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks. | 390 |
| Total | 779 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 63 | 65 |
| Overall Study | Never Initiated Treatment | 43 | 30 |
| Overall Study | Withdrawal by Subject | 1 | 10 |
Baseline characteristics
| Characteristic | Individual Acupuncture | Group Acupuncture | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 87 Participants | 73 Participants | 160 Participants |
| Age, Categorical Between 18 and 65 years | 303 Participants | 316 Participants | 619 Participants |
| Age, Continuous | 55.44 Years STANDARD_DEVIATION 13.2 | 54.19 Years STANDARD_DEVIATION 13.77 | 54.80 Years STANDARD_DEVIATION 13.49 |
| Age, Customized Median | 55.42 years | 54.93 years | 55.19 years |
| Annual Household Income $20-$29,000 | 44 Participants | 40 Participants | 84 Participants |
| Annual Household Income $30-$39,000 | 30 Participants | 41 Participants | 71 Participants |
| Annual Household Income $40-$49,000 | 21 Participants | 20 Participants | 41 Participants |
| Annual Household Income Don't know / Refused | 80 Participants | 83 Participants | 163 Participants |
| Annual Household Income Greater than $50,000 | 36 Participants | 22 Participants | 58 Participants |
| Annual Household Income Less than $20,000 | 179 Participants | 183 Participants | 362 Participants |
| Condition Participants were Referred to the Study for Back pain | 273 Participants | 261 Participants | 534 Participants |
| Condition Participants were Referred to the Study for Multiple conditions | 91 Participants | 77 Participants | 168 Participants |
| Condition Participants were Referred to the Study for Neck pain | 68 Participants | 70 Participants | 138 Participants |
| Condition Participants were Referred to the Study for Osteoarthritis | 112 Participants | 94 Participants | 206 Participants |
| Depression Score as Measured by Patient Health Questionnaire 9 question (PHQ-9) Score | 8.74 Score on a scale STANDARD_DEVIATION 6.07 | 8.75 Score on a scale STANDARD_DEVIATION 6.02 | 8.74 Score on a scale STANDARD_DEVIATION 6.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 224 Participants | 219 Participants | 443 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 159 Participants | 168 Participants | 327 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 2 Participants | 9 Participants |
| Household Income Support Any Support | 279 Participants | 270 Participants | 549 Participants |
| Household Income Support No support | 103 Participants | 114 Participants | 217 Participants |
| Participants Receiving Supplemental Security Insurance (SSI) Not Receiving SSI | 173 Participants | 212 Participants | 385 Participants |
| Participants Receiving Supplemental Security Insurance (SSI) Receiving SSI | 217 Participants | 177 Participants | 394 Participants |
| Participants Reporting Opioid Use at baseline No | 291 Participants | 275 Participants | 566 Participants |
| Participants Reporting Opioid Use at baseline Yes | 93 Participants | 106 Participants | 199 Participants |
| Participants with Health Insurance Coverage Medicaid | 288 Participants | 301 Participants | 589 Participants |
| Participants with Health Insurance Coverage None | 8 Participants | 8 Participants | 16 Participants |
| Participants with Health Insurance Coverage Other | 6 Participants | 4 Participants | 10 Participants |
| Participants with Health Insurance Coverage Private | 88 Participants | 76 Participants | 164 Participants |
| Patient Reported Global Health Score as Measured by The PROMIS-10 Excellent | 13 Participants | 13 Participants | 26 Participants |
| Patient Reported Global Health Score as Measured by The PROMIS-10 Fair | 145 Participants | 152 Participants | 297 Participants |
| Patient Reported Global Health Score as Measured by The PROMIS-10 Good | 104 Participants | 111 Participants | 215 Participants |
| Patient Reported Global Health Score as Measured by The PROMIS-10 Poor | 85 Participants | 80 Participants | 165 Participants |
| Patient Reported Global Health Score as Measured by The PROMIS-10 Very good | 42 Participants | 33 Participants | 75 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 22 Participants | 15 Participants | 37 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 134 Participants | 141 Participants | 275 Participants |
| Race (NIH/OMB) More than one race | 53 Participants | 43 Participants | 96 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 117 Participants | 138 Participants | 255 Participants |
| Race (NIH/OMB) White | 58 Participants | 46 Participants | 104 Participants |
| Region of Enrollment United States | 390 Participants | 389 Participants | 779 Participants |
| Sex: Female, Male Female | 312 Participants | 315 Participants | 627 Participants |
| Sex: Female, Male Male | 78 Participants | 74 Participants | 152 Participants |
| Spoken Language English | 290 Participants | 292 Participants | 582 Participants |
| Spoken Language Other | 0 Participants | 1 Participants | 1 Participants |
| Spoken Language Spanish | 81 Participants | 79 Participants | 160 Participants |
| Working Status Other | 199 Participants | 188 Participants | 387 Participants |
| Working Status Unable to Work Due to Disability | 147 Participants | 143 Participants | 290 Participants |
| Working Status Unemployed | 44 Participants | 58 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 389 | 1 / 390 |
| other Total, other adverse events | 10 / 389 | 5 / 390 |
| serious Total, serious adverse events | 0 / 389 | 0 / 390 |
Outcome results
Primary
Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)
The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in their pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed.
Time frame: Baseline, Week 12 (End of Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | >=30% Improvement in Pain Interference | 82 Participants |
| Group Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | <30% Improvement in Pain Interference | 189 Participants |
| Individual Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | >=30% Improvement in Pain Interference | 108 Participants |
| Individual Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | <30% Improvement in Pain Interference | 180 Participants |
p-value: 0.2495% CI: [-0.0058, 0.1506]Chi-squared
Primary
Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)
The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed.
Time frame: Baseline, Week 12 (End of Treatment)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | >=30% Improvement in Pain Interference | 65 Participants |
| Group Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | <30% Improvement in Pain Interference | 124 Participants |
| Individual Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | >=30% Improvement in Pain Interference | 81 Participants |
| Individual Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | <30% Improvement in Pain Interference | 123 Participants |
p-value: 0.1795% CI: [-0.0422, 0.1485]Chi-squared
Primary
Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)
The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.
Time frame: Baseline, Week 24 (12 weeks after treatment window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | <30% Improvement in Pain Interference | 191 Participants |
| Group Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | >=30% Improvement in Pain Interference | 77 Participants |
| Individual Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | >=30% Improvement in Pain Interference | 99 Participants |
| Individual Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | <30% Improvement in Pain Interference | 184 Participants |
p-value: 0.1795% CI: [-0.0151, 0.1401]Chi-squared
Primary
Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)
The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment). The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were included in the analysis.
Time frame: Baseline, Week 24 (12 weeks after treatment window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, lost to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | >=30% Improvement in Pain Interference | 56 Participants |
| Group Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | <30% Improvement in Pain Interference | 126 Participants |
| Individual Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | >=30% Improvement in Pain Interference | 78 Participants |
| Individual Acupuncture ITT | Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | <30% Improvement in Pain Interference | 119 Participants |
p-value: 0.495% CI: [-0.0075, 0.184]Chi-squared
Primary
Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)
The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much the participants' pain interferes with daily life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Investigators measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Week 12 | 5.1 Units on a Scale | Standard Deviation 3 |
| Group Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Baseline | 6.0 Units on a Scale | Standard Deviation 2.7 |
| Group Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Week 24 | 5.3 Units on a Scale | Standard Deviation 2.9 |
| Individual Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Baseline | 6.1 Units on a Scale | Standard Deviation 2.7 |
| Individual Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Week 12 | 4.8 Units on a Scale | Standard Deviation 3.1 |
| Individual Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Week 24 | 5.1 Units on a Scale | Standard Deviation 3.1 |
p-value: 0.069195% CI: [-0.772, 0.0291]ANCOVA
Primary
Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)
The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Baseline | 5.8 Units on a Scale | Standard Deviation 2.6 |
| Group Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Week 12 | 4.6 Units on a Scale | Standard Deviation 2.9 |
| Group Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Week 24 | 5.1 Units on a Scale | Standard Deviation 3 |
| Individual Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Baseline | 5.8 Units on a Scale | Standard Deviation 2.8 |
| Individual Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Week 12 | 4.5 Units on a Scale | Standard Deviation 3.1 |
| Individual Acupuncture ITT | Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Week 24 | 4.7 Units on a Scale | Standard Deviation 3.1 |
p-value: 0.507795% CI: [-0.6452, 0.319]ANCOVA
Secondary
Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Medical Record (EMR) Data (Intent to Treat Model)
Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME for participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months prior and post-treatment). A smaller MME indicates that the participant was using less medication. The definition of intent to treat is all participants who were randomized into treatment. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams).
Time frame: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
Population: The analysis is limited to participants who have documented opioid prescriptions in EMR. A participant could have a prescription in the pre-treatment period, post-treatment period or both.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group Acupuncture ITT | Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Medical Record (EMR) Data (Intent to Treat Model) | 0 Milligrams of Morphine Equivalents |
| Individual Acupuncture ITT | Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Medical Record (EMR) Data (Intent to Treat Model) | 0 Milligrams of Morphine Equivalents |
p-value: 0.129Wilcoxon (Mann-Whitney)
Secondary
Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Record (EMR) Data (Per Protocol Model)
Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME of participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months pre- and 3 months post-treatment). A smaller MME indicates that the participant was using less medication. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams).
Time frame: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
Population: The analysis is limited to participants who have documented opioid prescriptions in EMR. A participant could have a prescription in the pre-treatment period, post-treatment period or both.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group Acupuncture ITT | Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Record (EMR) Data (Per Protocol Model) | 0 Milligrams of Morphine Equivalents |
| Individual Acupuncture ITT | Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Record (EMR) Data (Per Protocol Model) | -0.5 Milligrams of Morphine Equivalents |
p-value: 0.031Wilcoxon (Mann-Whitney)
Secondary
Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model)
The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \>=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis.
Time frame: Week 12 (End of Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model) | Improved (>=6 point score) | 103 Participants |
| Group Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model) | Not improved (<=5 point score) | 191 Participants |
| Individual Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model) | Improved (>=6 point score) | 116 Participants |
| Individual Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model) | Not improved (<=5 point score) | 193 Participants |
p-value: 0.0395% CI: [-0.0517, 0.1018]Chi-squared
Secondary
Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model)
The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \>=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were included in the analysis.
Time frame: Week 12 (End of Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model) | Improved (>=6 point score) | 89 Participants |
| Group Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model) | Not improved (<=5 point score) | 117 Participants |
| Individual Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model) | Improved (>=6 point score) | 95 Participants |
| Individual Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model) | Not improved (<=5 point score) | 124 Participants |
p-value: 0.0295% CI: [-0.0925, 0.096]Chi-squared
Secondary
Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model)
The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \>=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.
Time frame: Week 24 (12 Weeks After Treatment Window
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model) | Improved (>=6 point score) | 76 Participants |
| Group Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model) | Not improved (<=5 point score) | 214 Participants |
| Individual Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model) | Not improved (<=5 point score) | 223 Participants |
| Individual Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model) | Improved (>=6 point score) | 75 Participants |
p-value: 095% CI: [-0.081, 0.0602]Chi-squared
Secondary
Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model)
The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \>=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.
Time frame: Week 24 (12 Week After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model) | Improved (>=6 point score) | 62 Participants |
| Group Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model) | Not improved (<=5 point score) | 136 Participants |
| Individual Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model) | Not improved (<=5 point score) | 139 Participants |
| Individual Acupuncture ITT | Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model) | Improved (>=6 point score) | 68 Participants |
p-value: 0.0395% CI: [-0.0755, 0.1063]Chi-squared
Secondary
Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \>=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis.
Time frame: Baseline, Week 12 (End of Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | >=5 point Improvement in Mental health | 75 Participants |
| Group Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | <5 point Improvement in Mental health | 213 Participants |
| Individual Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | >=5 point Improvement in Mental health | 84 Participants |
| Individual Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | <5 point Improvement in Mental health | 220 Participants |
p-value: 0.0195% CI: [-0.0555, 0.0873]Chi-squared
Secondary
Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \>=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis.
Time frame: Baseline, Week 12 (End of Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | >=5 point Improvement in Mental health | 48 Participants |
| Group Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | <5 point Improvement in Mental health | 155 Participants |
| Individual Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | >=5 point Improvement in Mental health | 57 Participants |
| Individual Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | <5 point Improvement in Mental health | 158 Participants |
p-value: 0.0595% CI: [-0.0544, 0.1117]Chi-squared
Secondary
Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \>=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.
Time frame: Baseline, Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | >=5 point Improvement in Mental health | 72 Participants |
| Group Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | <5 point Improvement in Mental health | 213 Participants |
| Individual Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | >=5 point Improvement in Mental health | 86 Participants |
| Individual Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | <5 point Improvement in Mental health | 209 Participants |
p-value: 0.0595% CI: [-0.0335, 0.1112]Chi-squared
Secondary
Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \>=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.
Time frame: Baseline, Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | >=5 point Improvement in Mental health | 45 Participants |
| Group Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | <5 point Improvement in Mental health | 152 Participants |
| Individual Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | >=5 point Improvement in Mental health | 59 Participants |
| Individual Acupuncture ITT | Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | <5 point Improvement in Mental health | 145 Participants |
p-value: 0.1895% CI: [-0.0247, 0.1463]Chi-squared
Secondary
Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)
The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed.
Time frame: Baseline, Week 12 (End of Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | >=30% Improvement in Pain Severity | 87 Participants |
| Group Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | <30% Improvement in Pain Severity | 198 Participants |
| Individual Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | >=30% Improvement in Pain Severity | 104 Participants |
| Individual Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) | <30% Improvement in Pain Severity | 195 Participants |
p-value: 0.0795% CI: [-0.0334, 0.1185]Chi-squared
Secondary
Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)
The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed.
Time frame: Baseline, Week 12 (End of Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | >=30% Improvement in Pain Severity | 73 Participants |
| Group Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | <30% Improvement in Pain Severity | 128 Participants |
| Individual Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | >=30% Improvement in Pain Severity | 83 Participants |
| Individual Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) | <30% Improvement in Pain Severity | 129 Participants |
p-value: 0.0795% CI: [-0.0651, 0.1218]Chi-squared
Secondary
Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)
The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were analyzed.
Time frame: Baseline, Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, lost to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | >=30% Improvement in Pain Severity | 65 Participants |
| Group Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | <30% Improvement in Pain Severity | 220 Participants |
| Individual Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | >=30% Improvement in Pain Severity | 74 Participants |
| Individual Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) | <30% Improvement in Pain Severity | 217 Participants |
p-value: 0.0295% CI: [-0.0436, 0.0961]Chi-squared
Secondary
Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)
The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were analyzed.
Time frame: Baseline, Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | >=30% Improvement in Pain Severity | 48 Participants |
| Group Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | <30% Improvement in Pain Severity | 148 Participants |
| Individual Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | >=30% Improvement in Pain Severity | 56 Participants |
| Individual Acupuncture ITT | Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) | <30% Improvement in Pain Severity | 146 Participants |
p-value: 0.0695% CI: [-0.0539, 0.1186]Chi-squared
Secondary
Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \>=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who have been randomized into treatment. Only patients who completed a week 12 questionnaire were included in the analysis.
Time frame: Baseline, Week 12 (End of treatment window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | >=2 point Improvement in Physical health | 173 Participants |
| Group Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | <2 point Improvement in Physical health | 118 Participants |
| Individual Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | >=2 point Improvement in Physical health | 193 Participants |
| Individual Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) | <2 point Improvement in Physical health | 113 Participants |
p-value: 0.0595% CI: [-0.0419, 0.1144]Chi-squared
Secondary
Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \>=2-point increase is considered a 30% improvement. The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis.
Time frame: Baseline, Week 12 (End of Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | >=2 point Improvement in Physical health | 125 Participants |
| Group Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | <2 point Improvement in Physical health | 79 Participants |
| Individual Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | <2 point Improvement in Physical health | 70 Participants |
| Individual Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) | >=2 point Improvement in Physical health | 147 Participants |
p-value: 0.2295% CI: [-0.0266, 0.156]Chi-squared
Secondary
Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \>=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.
Time frame: Baseline, Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | >=2 point Improvement in Physical health | 142 Participants |
| Group Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | <2 point Improvement in Physical health | 141 Participants |
| Individual Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | >=2 point Improvement in Physical health | 164 Participants |
| Individual Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) | <2 point Improvement in Physical health | 132 Participants |
p-value: 0.1295% CI: [-0.029, 0.1335]Chi-squared
Secondary
Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as a \>= 2-point increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.
Time frame: Baseline, Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | >=2 point Improvement in Physical health | 96 Participants |
| Group Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | <2 point Improvement in Physical health | 97 Participants |
| Individual Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | >=2 point Improvement in Physical health | 121 Participants |
| Individual Acupuncture ITT | Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) | <2 point Improvement in Physical health | 84 Participants |
p-value: 0.4495% CI: [-0.0047, 0.1903]Chi-squared
Secondary
Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model)
Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for this time point. This may have been due to withdrawal, loss to follow up, or declining to answer this question. Only participants who responded to having taken prescription opioids were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model) | Baseline | 4.3 Days of Opioid use | Standard Deviation 3.5 |
| Group Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model) | 12 weeks | 4.2 Days of Opioid use | Standard Deviation 2.8 |
| Group Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model) | 24 weeks | 4.5 Days of Opioid use | Standard Deviation 2.9 |
| Individual Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model) | 24 weeks | 5.1 Days of Opioid use | Standard Deviation 2.8 |
| Individual Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model) | Baseline | 5.1 Days of Opioid use | Standard Deviation 2.8 |
| Individual Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model) | 12 weeks | 4.9 Days of Opioid use | Standard Deviation 3.6 |
Comparison: Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.p-value: 0.0326Wilcoxon signed rank test
Secondary
Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model)
Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for this time point. This may have been due to withdrawal, loss to follow up, or declining to answer this question. Only participants who responded to having taken prescription opioids were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model) | Baseline | 4.0 Days of Opioid use | Standard Deviation 2.9 |
| Group Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model) | 12 weeks | 3.6 Days of Opioid use | Standard Deviation 2.8 |
| Group Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model) | 24 weeks | 4.1 Days of Opioid use | Standard Deviation 3 |
| Individual Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model) | Baseline | 4.7 Days of Opioid use | Standard Deviation 3 |
| Individual Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model) | 12 weeks | 4.2 Days of Opioid use | Standard Deviation 3.2 |
| Individual Acupuncture ITT | Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model) | 24 weeks | 5.0 Days of Opioid use | Standard Deviation 2.9 |
Comparison: Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.p-value: 0.0026Wilcoxon signed rank test
Secondary
Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)
The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and then divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is anyone who intended to receive treatment; in our case, it is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Baseline | 6.8 Units on a scale | Standard Deviation 1.8 |
| Group Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Week 12 | 5.7 Units on a scale | Standard Deviation 2.5 |
| Group Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Week 24 | 5.9 Units on a scale | Standard Deviation 2.6 |
| Individual Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Baseline | 6.8 Units on a scale | Standard Deviation 1.9 |
| Individual Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Week 12 | 5.4 Units on a scale | Standard Deviation 2.7 |
| Individual Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) | Week 24 | 5.8 Units on a scale | Standard Deviation 2.6 |
p-value: 0.138795% CI: [-0.6136, 0.0851]ANCOVA
Secondary
Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)
The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Baseline | 6.7 Units on a Scale | Standard Deviation 1.8 |
| Group Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Week 12 | 5.3 Units on a Scale | Standard Deviation 2.4 |
| Group Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Week 24 | 5.7 Units on a Scale | Standard Deviation 2.6 |
| Individual Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Baseline | 6.8 Units on a Scale | Standard Deviation 1.9 |
| Individual Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Week 12 | 5.1 Units on a Scale | Standard Deviation 2.7 |
| Individual Acupuncture ITT | Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) | Week 24 | 5.6 Units on a Scale | Standard Deviation 2.5 |
p-value: 0.272595% CI: [-0.6497, 0.1829]ANCOVA
Secondary
Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Baseline | 42.8 T-score | Standard Deviation 9.8 |
| Group Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Week 12 | 43.8 T-score | Standard Deviation 9.4 |
| Group Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Week 24 | 43.3 T-score | Standard Deviation 9.9 |
| Individual Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Baseline | 42.4 T-score | Standard Deviation 9.6 |
| Individual Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Week 12 | 44.5 T-score | Standard Deviation 9.6 |
| Individual Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Week 24 | 44.1 T-score | Standard Deviation 9.4 |
p-value: 0.401495% CI: [-0.6468, 1.6129]ANCOVA
Secondary
Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Baseline | 43.6 T-Score | Standard Deviation 9.6 |
| Group Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Week 12 | 44.4 T-Score | Standard Deviation 9.2 |
| Group Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Week 24 | 44.1 T-Score | Standard Deviation 9.7 |
| Individual Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Baseline | 43.5 T-Score | Standard Deviation 9.7 |
| Individual Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Week 12 | 45.2 T-Score | Standard Deviation 9.3 |
| Individual Acupuncture ITT | Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Week 24 | 45.0 T-Score | Standard Deviation 9 |
p-value: 0.30795% CI: [-0.61, 1.9334]ANCOVA
Secondary
Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Baseline | 34.8 T-score | Standard Deviation 7.2 |
| Group Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Week 12 | 38.5 T-score | Standard Deviation 8.4 |
| Group Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Week 24 | 37.2 T-score | Standard Deviation 8.7 |
| Individual Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Week 24 | 37.8 T-score | Standard Deviation 8.5 |
| Individual Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Baseline | 34.8 T-score | Standard Deviation 7.7 |
| Individual Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) | Week 12 | 38.7 T-score | Standard Deviation 8.3 |
p-value: 0.877895% CI: [-0.9659, 1.13]ANCOVA
Secondary
Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)
The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data..
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Week 12 | 39.4 T-score | Standard Deviation 8.3 |
| Group Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Baseline | 35.3 T-score | Standard Deviation 7.1 |
| Group Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Week 24 | 38.2 T-score | Standard Deviation 8.7 |
| Individual Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Baseline | 35.2 T-score | Standard Deviation 7.6 |
| Individual Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Week 12 | 39.6 T-score | Standard Deviation 8.1 |
| Individual Acupuncture ITT | Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) | Week 24 | 38.7 T-score | Standard Deviation 8.1 |
p-value: 0.562695% CI: [-0.8667, 1.5912]ANCOVA
Secondary
Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model)
Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of intent to treat is all participants who have been randomized into treatment. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for this time point. This may have been due to withdrawal, loss to follow up, or declining to answer this question. Only participants who responded to having taken prescription opioids were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model) | Opioid use within a week of Baseline | 85 Participants |
| Group Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model) | Opioid use within a week of Week 12 | 53 Participants |
| Group Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model) | Opioid use within a week of Week 24 | 58 Participants |
| Individual Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model) | Opioid use within a week of Baseline | 78 Participants |
| Individual Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model) | Opioid use within a week of Week 12 | 55 Participants |
| Individual Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model) | Opioid use within a week of Week 24 | 56 Participants |
Comparison: Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.p-value: 0.1658McNemar
Secondary
Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model)
Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of Per Protocol is all participants who have been randomized and who attended \>=8 sessions of acupuncture. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for this time point. This may have been due to withdrawal, loss to follow up, or declining to answer this question. Only participants who responded to having taken prescription opioids were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model) | Opioid use within a week of Baseline | 42 Participants |
| Group Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model) | Opioid use within a week of week 12 | 33 Participants |
| Group Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model) | Opioid use within a week of week 24 | 34 Participants |
| Individual Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model) | Opioid use within a week of Baseline | 39 Participants |
| Individual Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model) | Opioid use within a week of week 12 | 32 Participants |
| Individual Acupuncture ITT | Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model) | Opioid use within a week of week 24 | 35 Participants |
Comparison: Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.p-value: 0.1172McNemar
Secondary
Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model)
Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 months post-treatment). The definition of intent to treat is all participants who were randomized into treatment. There were 191 total participants that had any documented opioid prescriptions in EMR.
Time frame: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
Population: This analysis includes all participants who were randomized. A participant could have a prescription in the pre-treatment period, post-treatment period or both. Thus the total number of participants analyzed is not equal to the sum of participants in pre- and post-treatment periods.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model) | Opioid Prescription 3 Months Pre-Treatment | 51 Participants |
| Group Acupuncture ITT | Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model) | Opioid Prescription 3 Months Post-Treatment | 57 Participants |
| Individual Acupuncture ITT | Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model) | Opioid Prescription 3 Months Pre-Treatment | 64 Participants |
| Individual Acupuncture ITT | Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model) | Opioid Prescription 3 Months Post-Treatment | 43 Participants |
p-value: 0.0059Mixed Models Analysis
Secondary
Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model)
Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 month post-treatment). The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture.
Time frame: 6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)
Population: The analysis includes all participants who attended \>= 8 sessions. A participant could have a prescription in the pre-treatment period, post-treatment period or both. Thus the total number of participants analyzed is not equal to the sum of participants in pre- and post-treatment periods.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Acupuncture ITT | Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model) | Opioid Prescription 3 Months Pre-Treatment | 26 Participants |
| Group Acupuncture ITT | Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model) | Opioid Prescription 3 Months Post-Treatment | 28 Participants |
| Individual Acupuncture ITT | Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model) | Opioid Prescription 3 Months Pre-Treatment | 35 Participants |
| Individual Acupuncture ITT | Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model) | Opioid Prescription 3 Months Post-Treatment | 22 Participants |
p-value: 0.0385Mixed Models Analysis
Secondary
Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model)
The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model) | Week 12 | 3.0 Units on a Scale | Standard Deviation 1.9 |
| Group Acupuncture ITT | Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model) | Week 24 | 3.6 Units on a Scale | Standard Deviation 2.3 |
| Individual Acupuncture ITT | Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model) | Week 12 | 2.8 Units on a Scale | Standard Deviation 1.9 |
| Individual Acupuncture ITT | Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model) | Week 24 | 3.3 Units on a Scale | Standard Deviation 2.2 |
p-value: 0.147595% CI: [-0.5288, 0.0795]t-test, 2 sided
Secondary
Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model)
The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of Per Protocol is all participants who were randomized and who attended \>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.
Time frame: Week 12 (end of treatment window), and week 24 (12 weeks after treatment window)
Population: The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Acupuncture ITT | Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model) | Week 12 | 2.6 Units on a Scale | Standard Deviation 1.9 |
| Group Acupuncture ITT | Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model) | Week 24 | 3.3 Units on a Scale | Standard Deviation 2.3 |
| Individual Acupuncture ITT | Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model) | Week 12 | 2.5 Units on a Scale | Standard Deviation 1.9 |
| Individual Acupuncture ITT | Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model) | Week 24 | 3.0 Units on a Scale | Standard Deviation 2.2 |
p-value: 0.303895% CI: [-0.546, 0.1706]t-test, 2 sided